Investigator(s)
| WHO Technical Officer |
Herdiana Hasan Basri WHO Indonesia Herdiana Hasan Basri 
|
| Principal Investigator |
Din Syafruddin Department Parasitology, Faculty of Medicine, Hasanuddin University Din Syafruddin
|
| Co-Investigator(s) |
Puji Budi Setia Asih Eijkman Research Centre for Molecular Biology, National Research and Innovation Agency Puji Budi Setia Asih
|
Title(s) and abstract
| Scientific title | Therapeutic Efficacy Study (TES) for three antimalarial drugs (Dihydroartemisinin-Piperaquine/DHA-PPQ, Artesunate-Pyronaridine/ASPY, Artemether-Lumefantrine/AL) in Keerom and Yapen Regencies, Papua, Indonesia |
| Public title | TES three types of antimalaria drugs in Indonesia |
| Background | Malaria program in Indonesia have shown tremendous progress toward nationwide elimination by 2023. As of 2023, over 75% of 514 districts achieved elimination status as of 2023. However, Indonesia faces multifaceted challenges to eliminate malaria from entire country. Current national treatment protocol for malaria cases in Indonesia, the Ministry of Health utilizes artemisinin combined therapy (ACT) with type of Dihydroartemisinin-Piperaquine (DHA-PPQ) as first line drug since 2010 and non-ACT for second line drug. Taking into account WHO new recommendation to apply all ACTs at the first- and second-line treatment, and emergence of DHA-PPQ resistance at Great Mekong region and Africa. This proposed study will use WHO-guided Therapeutic Efficacy Study (TES) in Papua to assess efficacy and safety of DHA-PPQ, Artesunate-Pyronaridine (ASPY), and Artemether-Lumefantrine (AL) to inform treatment guidelines. This study aims to provide essential data on current treatment efficacy and explore alternative regiments in areas. The findings will guide the updated national treatment protocols and contribute to malaria elimination efforts, especially in high burden areas such Papua. |
| Objectives | The general objective of this study is to assess the therapeutic efficacy and safety of DHA-PPQ as a first-line malaria treatment policy and the candidate of second-line antimalarial drugs ASPY and AL, for uncomplicated P.falciparum and P. vivax malaria infections at Keerom and Yapen Regencies, Papua, Indonesia. The specific objectives are: • to measure the clinical and parasitological efficacy of DHA-PPQ, ASPY, and AL in patients aged between six months and 65 years old, suffering from uncomplicated falciparum or vivax malaria, by determining WHO-efficacy indicators (proportion of early treatment failure, late clinical failure, late parasitological failure, or an adequate clinical and parasitological response). • to differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis. The secondary objectives are: • to evaluate the incidence of adverse events • to measure the proportion of patients with delayed clearance of parasitemia on day 3 following treatment. • to determine the mutations in PfK13, PfCRT and Pfmdr1 genes copy number of the Pfplasmepsin 2 gene. • to observe the gametocyte carriage during the follow-up period. |
| Study Methods | This study is a single-arm prospective and will determine the efficacy and safety of DHA-PPQ, ASPY, and AL for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria infections at two sites of Papua region: Keerom and Yapen Districts. A total of 360 cases of malaria mono-infection (60 with P. falciparum and 60 with P. vivax malaria) will be enrolled in each site per each antimalarial drug. The study population will include individuals from six months to 65 years of age. The dose of combined DHA-PPQ used in this study will be according to the national treatment protocol, While the dose of AL and ASPY will be referred to WHO guideline. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy. Study methodology, design and sample size follow standard WHO tool for monitoring antimalarial drug efficacy at https://www.who.int/malaria/areas/drug_resistance/efficacy-monitoring-tools/en/. |
| Expected outcomes and use of results | The primary outputs of the study are proportion of malaria cases with: early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. In addition to the primary outputs, other outputs that will be obtained from this study are frequency and severity of adverse events, recrudescence, polymorphism of molecular markers for the antimalarial drug(s) resistance, and gametocyte. The use of the results will be used to inform the updated national treatment protocol of MOH Indonesia and incorporated into WHO database on malaria drug resistance. The research team and WHO will publish the findings in the peer-review journal. |
| Keywords | malaria, efficacy, medicines, Indonesia, Papua |
Research Details
| Student research | No |
| Start Date | 15-Nov-2024 |
| End Date | 31-Oct-2025 |
| Key Implementing Institution | Department Parasitology, Faculty of Medicine, Hasanuddin University |
| Multi-country research | No |
| Nationwide research | No |
| Indonesia | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Malaria |
| Involves human subjects | Yes |
| Intervention Evaluation Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |